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This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the 24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in which they will receive a single intravenous infusion of active drug or placebo. Placebo will be normal saline. Volunteers will be followed for safety for up to 120 days after infusion depending on dose cohort.

Pharmacokinetics of XOMA 3AB:Area under the curve to the last time with a measurable value (AUC(0-t)) [ Time Frame: Serially on day 0, 1, 2, 3, 7, 14, 28, 42, 56, 90 and 120 days (depending on dose cohort) ]

Single intravenous infusion of XOMA 3AB in three cohorts at different concentrations.

Detailed Description:

This is a phase I, single-center, placebo-controlled, double-blinded, dose escalation study of anti-botulinum toxin monoclonal antibodies in healthy adult volunteers. Volunteers will be hospitalized in the Johns Hopkins Phase 1 unit during the infusion and until after the 24-hour blood draw. Three escalating dose cohorts of a combination of three anti-botulinum monoclonal antibodies will be evaluated. Each cohort will consist of eight volunteers in which they will receive a single intravenous infusion of active drug or placebo. Placebo will be normal saline. Volunteers will be followed for safety for up to 120 days after infusion depending on dose cohort.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 45 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Informed consent understood and signed

Healthy male or healthy, non-pregnant, non-lactating female

Willingness to comply and be available for all protocol procedures

Age between 18 and 45 years, inclusive on the day of infusion

Body Mass Index of < 35

Blood pressure within acceptable limits (systolic blood pressure </=140mmHg and diastolic blood pressure </=90mmHg). If subject is receiving anti-hypertensive medications, blood pressure must be well controlled with no changes in anti-hypertensive medications for at least 3 months.

If the subject is female and of childbearing potential, negative serum pregnancy test at screening and negative urine or serum pregnancy test within 24 hours prior to infusion.

If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception, for the duration of the study:

A woman is considered of childbearing potential unless post-menopausal (>/= 1 year without menses) or surgically sterilized (tubal ligation, bilateral oophorectomy, or hysterectomy)

Acceptable contraception methods are restricted to effective devices (Intrauterine Contraceptive Devices (IUDs), NuvaRing®) or licensed hormonal products with use of method for a minimum of 30 days prior to vaccination, condoms with spermicidal agents, monogamous relationship with a vasectomized partner, or successful Essure placement with documented confirmation test at least 3 months after the procedure.

All requested screening laboratory values are within the range specified in the table, "Acceptable Ranges of Screening Labs and Vital Sign Measurements" (Appendix B).

Has adequate venous access for the infusion.

The drug screen is negative

Breathalyzer test is negative.

Exclusion Criteria:

History of a chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart or nervous system, or other metabolic and autoimmune/inflammatory conditions that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject such as:

Diabetes

Asthma requiring use of medication in the year before screening

Autoimmune disorder, such as lupus, Wegener's, rheumatoid arthritis

Coronary artery disease

History of malignancy except low-grade (squamous and basal cell) skin cancer thought to be cured

Chronic renal hepatic or pulmonary disease (except previous asthma which has required no treatment for the past year)

History of severe allergic reaction of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobulins. Severe allergic reaction is defined as any of the following: